On May 24, 2011 and May 25, 2011, a representative of the United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located at J1. Muara Dermaga Timor Transit #7, Jakarta, Indonesia 14440. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). The inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection listing the deviations found at your firm. We received your responses to the FDA-483 dated June 7, 2011 and September 7, 2011. Our review of the documentation revealed that the responses were not adequate, as further described in this letter.

In accordance with Title 21, Code of Federal Regulations, Section 123.6(g) [21 CFR 123.6(g)], failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your Snapper, Grouper and Tuna are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

FDA has recently published a 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (i.e., the Hazards Guide). You may find the Act, the seafood HACCP regulation, and the Hazard Guide through links in FDA's home page at www.fda.gov. We have made references to the 4th Edition in our comments below. In addition, the observations will be specific to your responses received by the FDA on 6/7/2011 and 9/7/2011.

Based on our review of the HACCP documents and the information provided in the EIR dated 05/24/2011-05/25/2011 relative to your Tuna products, it appears your firm acts both as a “primary” processor receiving fish directly from the fishing vessel and a “secondary” processor receiving the fish in transit (i.e., from the dock where they were unloaded from the harvest vessels) to your processing facility. As such, your firm is responsible for both primary and secondary processor controls at receiving to control scombrotoxin (histamine) formation. We suggest that you refer to Chapter 7 of the 4th Edition of the Hazards Guide for additional information. Specifically:

as a primary processor, your firm should refer to pages 125 to 136 of the 4th Edition of the Hazards Guide and adopt either a histamine testing strategy or a harvest vessel record strategy as a primary processor. In addition, as a primary processor your firm will be responsible for sensory evaluation on a representative number of fish to ensure that the fish were properly handled on board the harvest vessels.

as a secondary processor, your firm should refer to pages 137 to 144 of the 4th Edition of the Hazards Guide and adopt a transit control strategy because the fish are in transit for an extended time period from the dock (i.e., where they were off-loaded from the harvest vessels) to your facility. This is to ensure that the fish were held under proper conditions during transit to your facility.

In your response, please provide additional information about how fish are received from the fishing vessel and how they are transported to the processing facility.

We have reviewed the revised HACCP plans provided in your responses and note the following deviations.:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plans for a) Fresh Snapper and Grouper Fillet and b) Fresh Snapper and Grouper Whole submitted with your 6/7/2011 response do not list the hazards of Ciguatera Fish Poisoning (CFP) or Environmental Chemicals. While your response references “Certification of Ciguatera” from your government, your HACCP plans should include controls to ensure that the fish you receive are harvested from waters that are free from ciguatera and environmental chemicals.

Your response indicates that the Ministry of Maritime Affairs and Fisheries has not found ciguatera in the waters they are testing; however, the fact that they have a testing program in place indicates that ciguatera is a likely hazard and should be included in your HACCP plans. Please refer to Chapters 6 and 9 of the 4th Edition of FDA’s Fish and Fishery Products Hazards and Controls Guidance at www.fda.gov for additional information on recommended control strategies for these hazards.

2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plans received with your response dated 9/7/2011 for a) Fresh Tuna Loin Product and b) Fresh Tuna HG, GG Product do not list the critical control point of Processing (including the steps of chilling, washing, de-heading, loining, skinning, trimming, weighing, wrapping, packing, labeling and stuffing) for controlling the food safety hazard of histamine. For additional information related to the processing critical control point, please refer to pages 142 to 145 in the 4th Edition of the Hazards Guide.

Your HACCP plans state a critical limit where all fish are delivered by (b)(4). This appears to be associated with your firm’s receipt of the fish as a secondary processor, receiving the fish after they have been in transit from the dock (i.e., where they were off-loaded from the harvest vessels) to your facility. However, you do not list monitoring procedures to determine either the (b)(4) or the temperature of the truck during transport or at the time of delivery. For example, (b)(4) (i.e., as one of your listed critical limits) will not provide any information related to the temperature of the fish; conversely, monitoring the temperature of the fish (i.e., listed as the other critical limit) will not provide any information related to the adequacy of ice. Your firm needs to implement monitoring procedures that correlate to your critical limits.

Your HACCP plans state you will measure the internal temperature of a representative number of the (b)(4). This appears to be related to your firm’s activity as a primary processor receiving the fish directly from the harvest vessels. However, FDA recommends that internal temperatures be taken immediately after fish are off loaded from the harvest vessel to ensure that adequate cooling occurred onboard the harvest vessel. Then, upon receipt at your processing facility, (b)(4), as a secondary processor element. These transit controls are in addition to histamine testing and sensory examinations upon receipt at the processing facility. Please be aware that a single lot of fish consists of a single species of fish.

4.Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for a) Fresh Tuna Loin Product and b) Fresh Tuna HG, GG Product, received on 9/7/2011 at the (b)(4) critical control point to control histamines is not appropriate because it does not prevent distribution of potentially adulterated product. Specifically, your plan lists that when a product violates a temperature or delivery truck temperature critical limit, your corrective action is to discontinue use of the supplier until evidence is obtained that harvesting practices have changed. However, this corrective action does not include an action related to what will be done with the product that has violated your critical limits. FDA recommends either rejecting the entire lot or, holding and chilling the product until additional histamine analysis can be performed on a minimum of 60 fish representatively collected from throughout the lot, as described on pages 128 and 134 of the 4th Edition of the Hazards Guide.

In order to obtain an accurate result when performing histamine analyses, FDA recommends sampling a minimum of 250 grams of tissue from the lower anterior loin portion (nearer to the head).

In addition, during the inspection, FDA noted that your firm’s HACCP plans for a) Fresh Tuna Loin Product and b) Fresh Tuna HG, GG Product list a critical limit of (b)(4) at the Receiving Critical Control Point. This critical limit is not adequate to control histamine formation associated with a primary processor receiving the fish from the harvest vessels. For sensory examinations, FDA recommends a critical limit of “less than 2.5% decomposition” in the incoming lot.

FDA is also concerned with your firm’s practice of storing finished product in insulated (b)(4) for an extended period of time may allow more rapid depletion of the cooling media (dry ice). It may be more appropriate for your firm to store shipping containers under refrigeration prior to shipping. In your response, please provide additional information about the length of time and the ambient temperatures these shipping containers are exposed to ambient temperatures before they are shipped.

For additional information and guidance please refer to Chapters 6 and Chapter 7, Natural Toxins and Scombrotoxin (Histamine) Formation respectively, in the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.

This letter may not list all your deviations from the requirements of the Act or applicable regulations. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Current Good Manufacturing Practice regulation for food (21 CFR Part 110). You also have a responsibility

to use procedures to prevent further violations of the Act and all applicable regulations.

You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as: a copy of any revised HACCP plans; at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan; any verification records; and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, you should explain the reason for your delay and state when you will correct any remaining violations.

If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. This alert can be found on FDA’s web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.html